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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name trichomonas vaginalis nucleic acid amplification test system
510(k) Number K102911
Model 302806
Device Name APTIMA TRICHOMONAS VAGINALIS ASSAY
Original Applicant
GEN-PROBE INCORPORATED
10210 genetic center drive
san diego,  CA  92121
Original Contact maria carmelita s baluyot
Regulation Number866.3860
Classification Product Code
OUY  
Date Received10/01/2010
Decision Date 04/19/2011
Decision de novo petitions granted (AN)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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